Associate Director, Clinical PharmacologyThe Associate Director of Clinical Pharmacology will play a critical role in the design, execution, analysis, and interpretation of clinical pharmacology strategies across City Therapeutics' development programs. This individual will report to the Head of Clinical Pharmacology and Pharmacokinetics (CPPK), and provide scientific leadership for pharmacokinetic (PK), pharmacodynamic (PD), exposure-response, and dose selection activities from first-in-human studies through late-stage clinical development.
The successful candidate will work in a highly cross-functional environment, partnering closely with Clinical Development, Regulatory Affairs, Clinical Operations, Biostatistics, Data Science, CMC and external collaborators to drive data-driven decision making and advance clinical development.
Key Responsibilities- Lead development and execution of clinical pharmacology strategies for RNAi therapeutic clinical programs.
- Lead and execute model-informed drug development (MIDD) activities, including population PK, exposure-response, PBPK, and mechanistic PK/PD modeling, either independently or in collaboration with quantitative scientists, to support regulatory interactions and development planning.
- Contribute to clinical protocol design, statistical analysis plans, clinical study reports, and investigator brochures.
- Author and review clinical pharmacology sections of regulatory documents including INDs, briefing packages, meeting requests, and marketing applications.
- Participate in interactions with health authorities and contribute to regulatory strategy discussions.
- Develop dose selection and dose optimization strategies to support clinical development and regulatory submissions.
- Integrate nonclinical, translational, biomarker, PK/PD, and clinical data to inform clinical development decisions.
- Review emerging clinical data and communicate pharmacology insights to project teams and senior leadership.
- Ensure clinical pharmacology plans align with current regulatory expectations and industry best practices.
Qualifications- PhD, PharmD, MD, or equivalent advanced degree in Clinical Pharmacology, Pharmaceutical Sciences, Pharmacokinetics, Pharmacometrics, Biomedical Engineering, or a related discipline.
- 7+ years of relevant industry experience in clinical pharmacology or pharmacometrics.
- Demonstrated experience supporting early and/or late-stage clinical development programs.
- Experience leading clinical pharmacology activities across multiple development programs and regulatory interactions.
- Hands-on experience with population PK modeling and exposure-response analyses for dose recommendation and optimization.
- Experience working with external CROs and pharmacometric vendors.
- Knowledge of regulatory expectations related to clinical pharmacology and model-informed drug development.
- Experience contributing to CTA, IND, NDA, BLA, or equivalent regulatory submissions.
- Excellent scientific communication and presentation skills.
- Ability to influence cross-functional teams in a fast-paced biotechnology environment.
- Prior participation in FDA, EMA, or other global regulatory agency interactions.
- Familiar with translational biomarkers and precision medicine approaches.
- Experience in oligonucleotide therapeutics, i.e. siRNA, antisense, gene editing, or other nucleic acid-based modalities.
CompensationThe base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package. Pay range is $174,000 to $196,000
